Utah-based Dolor Technologies, LLC, entangled in legal woes, has agreed to settle allegations it sold a migraine treatment device in violation of the False Claims Act. The device in question, known as the SphenoCath, pitched as a migraine miracle cure, was used for treatments not approved by the FDA, as reported by the Department of Justice on Monday.
According to the accusations, from July 2013 to July 2017, Dolor engaged in shady practices that led health providers to bill Medicare with false claims for the unapproved usage of the SphenoCath device. The stickler is that the device was allegedly marketed for administering nerve blocks to the sphenopalatine ganglion—a procedure not authorized by the FDA. Following Dolor's instructions, medical providers were encouraged, coached, and even instructed to use improper billing codes so Medicare would pay out for these illegitimate services.
In a damning statement obtained by the Department of Justice, U.S. Attorney Rachelle Aud Crowe came down hard on the malpractice. "Device companies that evade the FDA approval process and improperly promote their products undermine the health of patients and the financial integrity of federal health care programs," she was quoted. "This settlement demonstrates the commitment of our office and investigative partners to combat health care fraud against the Medicare Program."
In related developments, Dolor's former CEO, Mark Wright, pleaded guilty to charges of introducing misbranded and adulterated devices into the market. Wright admitted in an October 11 hearing that the company bypassed FDA regulations, pushing SphenoCath into the hands of consumers without the necessary approval. Even after the FDA's advice in April 2014 to carry out studies on SphenoCath's safety and effectiveness, Dolor instead continued with the headstrong marketing of the device intended for migraines.
Special Agent in Charge Mario M. Pinto from the HHS-OIG reflected on the devastating impact fraudulent activities have on government programs, stating, "The submission of false claims to Medicare undermines the solvency of our federal health care programs and wastes valuable taxpayer dollars." His words emphasize the gravity of the situation and the government's zero-tolerance stance on such fraudulent acts.
